To evaluate participant satisfaction and effectiveness of the CoolSculpting Elite System using CoolSculpting Elite applicators for non-invasive subcutaneous fat reduction of the abdomen and flanks, upper arms, inner thighs, outer thighs and…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Non-Invasive Fat Reduction
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary effectiveness endpoint is the proportion of participants with
*satisfied* or *very satisfied* on the item 1 for the CSQ-Midsection, measured
at Week 12 (Visit 8) for participants who receive 1 treatment session, or at
Week 20 (Visit 9) for participants who receive 2 treatment sessions
Secondary outcome
* The proportion of participants who received treatment to abdomen and flank
and one or more additional body areas for treatment with *satisfied* or *very
satisfied* on CSQ-Overall Item 1 measured at Week 12 (Visit 8,12-week follow-up
for participants who receive only 1 treatment session to all treated body
areas) or at Week 20 (Visit 9, 12-week follow-up for participants who receive 2
treatment sessions to any or all treated body areas).
* The proportion of participants with *satisfied* or *very satisfied* on
individual treated body area (upper arms, inner thighs, outer thighs, fat under
chin) CSQ Item 1 measured at Week 12 (Visit 8, 12-week follow-up for
participants who receive only 1 treatment session) or at Week 20 (Visit
9,12-week follow-up for participants who receive 2 treatment sessions) for the
respective treated body areas.
* Correct identification of baseline vs 12-week post-final treatment images of
the treated body area(s) by at least two out of three blinded, independent
reviewers for the following body areas:
o Midsection
o Upper arms
o Inner thighs
o Outer thighs
o Submental area
Success will be defined as at least 70% correct identification of the
pre-treatment images.
Background summary
CoolSculpting is a noninvasive, clinically proven fat-reduction treatment that
selectively targets adipocytes using a patented cooling technology. The
CoolSculpting mechanism of action is based on cryolipolysis, which works by
cooling the subcutaneous tissue and preferentially targets adipocytes, leading
to controlled elimination of adipocytes (Manstein 2008, Zelickson 2009).
Adipose tissue appears more preferentially sensitive to cold injury than skin
and other tissues (eg, skin, muscle, and nerve) and the crystallization of
cytoplasmic lipids in adipocytes occurs at temperatures well above the freezing
point of water (Epstein 1970, Beacham 1980, Manstein 2008).
While the CoolSculpting procedure is successful in reducing subcutaneous fat in
various anatomical areas, patients often desire treatment in multiple body
areas and typically more than one treatment session may be necessary to achieve
desired results. Retrospective chart reviews indicate patients most commonly
seek treatment for the abdomen and/or flanks and there is demand to treat other
body areas beyond the midsection. In addition, physician feedback suggested
that patients would prefer to have multiple CoolSculpting cycles performed at
once in a single office visit to reduce the overall time of the procedures. The
present study is intended to be reflective of real-world treatment
consultations where one or more body areas can be considered for treatment. In
addition, capabilities of the device to allow for simultaneous use of
applicators would allow for treatment of multiple body areas in the same or
reduced treatment time.
Although there are numerous clinical studies that have been conducted with the
prior CoolSculpting system, there have been a limited number of patients who
have been studied with the CoolSculpting Elite device and applicators globally
with treatment plans facilitating simultaneous applicator use and multiple body
areas. There is a need to evaluate effectiveness, safety, and patient-centric
outcomes related to the CoolSculpting Elite procedure as well as to generate
data with the updated applicators across body areas.
Study objective
To evaluate participant satisfaction and effectiveness of the CoolSculpting
Elite System using CoolSculpting Elite applicators for non-invasive
subcutaneous fat reduction of the abdomen and flanks, upper arms, inner thighs,
outer thighs and submental area.
To evaluate safety of the CoolSculpting Elite System using CoolSculpting Elite
applicators for non-invasive subcutaneous fat reduction of the abdomen and
flanks, upper arms, inner thighs, outer thighs and submental area.
Study design
This is a global, multicenter, multi-country, prospective, open-label,
nonrandomized, interventional cohort, medical device post-marketing study
evaluating the use of CoolSculpting Elite and CoolSculpting Elite applicators
for noninvasive subcutaneous fat reduction of the abdomen, flanks, upper arms,
inner thighs, outer thighs, and/or submental area in healthy volunteers.
Participants will be enrolled at approximately 9 study sites.
Participants are eligible to receive up to two treatment sessions separated 8
weeks apart for the body areas eligible for treatment. Assessments will be
completed 12 weeks after the final treatment session.
Participant body areas selected for treatment during the study must be treated
during the first treatment visit (Visit 2) and no new body areas may be treated
at Visit 6. Participants planning to receive only one treatment session to a
specific body area must have this treatment in Visit 2 during the first
treatment session. Per investigator discretion, body areas identified for
treatment may be treated simultaneously or sequentially. If sequential or
simultaneous treatment is performed, there will be no difference in other
treatment activities. Skin preparation, pain assessment, treatment site
assessment, and post-massage, etc. will be identical in either case.
The study duration is up to approximately 20 weeks and consists of up to 7
scheduled study visits and 2 phone follow-ups per participant.
Intervention
Participants will undergo a CoolSculpting Elite treatment in an outpatient
clinical setting. A treatment is comprised of timed segments of cooling
(treatment cycle) followed by 2 minutes of manual massage. Treatments will be
administered according to the CoolSculpting Elite user manual that has been
prepared for specific countries and provided to the study sites. All device
deficiencies (including malfunction and use error) shall be documented and
reported by the investigator throughout the clinical investigation and
appropriately managed by the sponsor.
Study burden and risks
There is no guarantee that participants will receive any benefits from their
participation in this study. They may receive a cosmetic (aesthetic) benefit
and the use of this non-invasive system may eliminate the need for an invasive
procedure that requires anesthesia or recovery time to remove unwanted fat.
The treatment may cause side effects, which may be mild or serious. In some
cases, these effects might be long lasting or permanent, and may even be life
threatening. The risks and discomforts described below are related to
receiving any CoolSculpting Elite study treatment:
Risks from device effects:
* Inflammation of the subcutaneous (under the skin) fat layer, which is a
desired, expected and temporary effect of the procedure;
* Sensations of coldness, stinging, burning, pinching, pulling, or pressure
associated with placement of the applicator and the initiation of the cold
study treatment;
* Known skin effects (for example, blanching [skin becomes white or paler than
usual]; erythema/redness, bruising, purpura or blood spots, petechiae (tiny red
brown spots caused by bleeding into the skin), swelling, discomfort,
tenderness, or soreness at the study treatment area, all mild to moderate in
nature), which are temporary effects that resolve spontaneously shortly after
the procedure; and
* Localized sensory changes (for example, numbness, tingling) at the study
treatment area resolving within 12 weeks of the procedure.
Risks and discomforts that may potentially be experienced include:
* Severe bruising
* Prolonged bruising
* Severe erythema (skin redness)
* Prolonged erythema (skin redness)
* Severe swelling
* Prolonged swelling
* First degree burn
* Second degree burn
* Third degree burn
* Severe pain
* Cold-induced panniculitis (inflammation of the fatty layer under the skin)
* Skin pigment changes (change in skin color)
* Infection
* Discomfort during the procedure
* Discomfort after the procedure
* Prolonged sensory alteration (changes in sensation) after the procedure
* Sensory alteration (changes in sensation) requiring medical intervention
* Vasovagal symptoms (dizziness and fainting)
* Contour irregularity (lumpiness and unevenness of the skin)
* Allergic/irritant contact dermatitis (red, itchy rash due to an allergic
reaction or irritation)
* Subcutaneous induration (hard nodules beneath the skin)
* Paradoxical adipose hyperplasia (enlargement and hardening of treated area)
* Hernia (fatty tissue may squeeze through a weak spot in the surrounding
muscle or connective tissue)
* Treatment area demarcation (indentation from removing too much fat)
Dupont Drive 2525
Irvine CA 92612
US
Dupont Drive 2525
Irvine CA 92612
US
Listed location countries
Age
Inclusion criteria
1. Participant must be in good health as determined by medical history,
physical examination, vital signs, and investigator*s judgment, including no
known active pandemic infection.
2. Participant (healthy volunteers) has read and signed the study written ICF.
3. Male or female participant 22 to 65 years of age inclusive at screening.
4. Participant has clearly visible and palpable fat in the abdomen and flanks,
and participant may also be assessed for visible and palpable fat in one or
more of the following body areas: left and right lower aspects of the upper
arms, left and right inner thigh, left and right outer thigh, or submental
area, which in the investigator*s opinion is appropriate for and may benefit
from treatment.
5. Participant agrees to receive treatment of the abdomen and flanks
(collectively, the midsection) and has option to receive treatment to at least
1 additional body area listed in criterion 4.
6. Participant has not had weight change fluctuations exceeding 5% of body
weight in the preceding month.
7. Participant has a BMI of * 18.5 and < 30. BMI is defined as weight in
kilograms divided by height in meters squared (kg/m2).
8. Participant agrees to maintain weight (ie, within 5% of body weight) by not
making any changes in diet or exercise routine during the course of the study.
9. Participant agrees to have photographs taken of the treatment area(s) during
the scheduled time periods
Exclusion criteria
1. Participant has a history of an invasive fat reduction procedure (eg,
liposuction, surgery, lipolytic agents, etc) within or adjacent to the area
being considered for treatment.
2. Participant has implants (eg, breast implants) in or immediately adjacent to
the area of intended treatment.
3. Participant has a history of prior surgery or scar tissue related to the
area being considered for treatment.
4. Participant has a known history of cryoglobulinemia, cold urticaria, cold
agglutinin disease, or paroxysmal cold hemoglobinuria.
5. Participant has a known sensitivity to cold or has any condition with a
known response to cold exposure that limits blood flow to the skin, such as
cold urticaria, Raynaud*s disease, or chilblains (pernio).
6. Participant with a clinically significant bleeding disorder, or concomitant
use of blood thinners, or is taking any medication that, in the investigator*s
opinion, may significantly increase the participant*s risk of bruising or
bleeding. Participant on low dose aspirin for medical condition is excluded if
the medical history suggests significant risk of bruising or bleeding per
investigator*s clinical judgement.
7. Participant has a history of carpal tunnel syndrome, compartment syndrome,
or deep vein thrombosis in the upper or lower extremities (only applicable for
participants receiving treatment to the upper arms or thighs).
8. Participant is currently taking or has taken diet pills or weight control
supplements within the past 6 months.
9. Participant has any skin conditions, such as moderate to excessive skin
laxity, open wound, or scars, and active infection, eczema, dermatitis or
rashes in the location of the treatment sites that may interfere with the
treatment or evaluation (stretch marks are not an exclusion).
10. Participant has an active implanted device such as a pacemaker,
defibrillator, drug delivery system, or any other metal-containing implant,
within or adjacent to the area being considered for treatment.
11. Participant (WOCBP) is pregnant or intending to become pregnant in the next
3 to 6 months and does not agree to use reliable contraception during the study.
12. Participant is lactating or has been lactating in the past 6 months.
13. Participant is unable or unwilling to comply with the study requirements.
14. Participant is currently enrolled in a clinical study of any unapproved
investigational device, investigational product, or any other type of medical
research judged not to be scientifically or medically compatible with this
study.
15. Participant has any other condition or laboratory value that would, in the
professional opinion of the investigator, potentially affect the participant*s
response or the integrity of the data or would pose an unacceptable risk to the
participant.
16. Participant has had a non-invasive fat reduction and/or body contouring
procedure in the area(s) of intended treatment within the past 12 months.
17. Participant needs to administer, or has a known history of subcutaneous
injections, into the area(s) of intended treatment (eg, cortisone, heparin,
insulin) within the past 6 months.
18. Participant with known sensitivity or allergy to fructose, glycerin,
isopropyl alcohol, or propylene glycol.
19. Participant has impaired peripheral circulation in the area to be treated.
20. Participant has neuropathic disorders such as post-herpetic neuralgia or
diabetic neuropathy.
21. Participant has impaired skin sensation in or immediately adjacent to the
treatment area(s).
22. Participant has a history of hernia in or immediately adjacent to the
treatment area(s).
23. Participant diagnosed with a systemic fibrosing disease or fibrosis in the
area intended or adjacent to the area to be treated.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77649.100.21 |